Senior QC Data & Compliance Specialist

Capricor Therapeutics, Inc.; San Diego (CA); On-site; USD 100,000 - 120,000; Full time

Job summary

Capricor Therapeutics, Inc. is seeking a QC Specialist, Analytical to ensure quality systems and data integrity for cell therapy programs.

You will review QC data, lead investigations, write technical documentation, and trend data to identify risks to product quality. The role emphasizes cross-functional collaboration with QA, Manufacturing, and external partners to maintain cGMP standards.

Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, or related field (advanced degree preferred).
• ~5–8+ years of experience in GMP Quality Control, Quality Assurance, or related function within biotech or pharmaceutical industry.
• Strong knowledge of cGMP, FDA/EMA regulations, and ICH guidelines.
• Experience with deviation investigations, OOS/OOT, CAPAs, and change control processes.
• Strong technical writing, data analysis, and problem-solving skills.
• Working knowledge of analytical methods such as flow cytometry, PCR, ELISA, and bioassays.
• Excellent communication skills and ability to collaborate in a cross-functional environment.
• High attention to detail and commitment to quality and compliance.

Responsibilities

• Lead and support investigations related to deviations, OOS/OOT/invalid results, and CAPAs, ensuring thorough root cause analysis and clear documentation.
• Review QC data, laboratory records, and analytical results to assess product impact and ensure compliance with cGMP standards.
• Author and review SOPs, test methods, validation protocols/reports, and investigation summaries.
• Perform data trending and analysis to identify variability, shifts, or emerging risks in QC and product quality data.
• Support method lifecycle activities including qualification, validation, transfer, and periodic review in collaboration with Analytical Development.
• Provide technical oversight of QC methods to ensure they remain scientifically sound and fit for purpose.
• Contribute to change control activities and assess potential impact to product quality and method performance.
• Support maintenance of product specifications, including acceptance criteria and scientific justification.
• Participate in stability program activities, including data review and trending to support shelf-life determinations.
• Ensure accurate, complete, and compliant GMP documentation in alignment with data integrity (ALCOA+) principles.
• Support audits and regulatory inspections by preparing and reviewing technical documentation.
• Collaborate cross-functionally with QA, Manufacturing, and external partners to support product quality objectives.
• Contribute to quality risk assessments (ICH Q9), continuous improvement initiatives, and quality system enhancements.

Skills

GMP Quality Control

Quality Assurance

Data analysis

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

Flow cytometry

PCR

ELISA

Bioassays

Job description

Capricor Therapeutics, Inc. is seeking a QC Specialist, Analytical to ensure quality systems and data integrity for cell therapy programs.

You will review QC data, lead investigations, write technical documentation, and trend data to identify risks to product quality. The role emphasizes cross-functional collaboration with QA, Manufacturing, and external partners to maintain cGMP standards.